DepressionVR-KETNCT06139016
Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment
A study testing Virtual reality in people with Depression, run by Yale University at 1 site in United States.
Trial summary
Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2024to 27 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be at least 18 years old
- Patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment Written consent for the study procedures
- Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.
Who cannot join
- Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content.
- Difficulty in understanding spoken or written English
- Unable to provide informed consent
- Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment)
- Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
- Was previously enrolled/randomized into the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit
New Haven, Connecticut, 06520
About this study
Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether these tools can improve the tolerability and effectiveness of treatment with ketamine/esketamine
- Conditions
- Depression
- Being tested
- Virtual reality
- Keywords
- ketamine, esketamine, virtual reality
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Virtual reality gear and content will be used to affect and control the audiovisual perception of patients during a single treatment with ketamine/esketamine
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | This single arm will include all participants of the study, who will all receive the intervention Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of VR Treatment Assessed by Qualitative Report
Tolerability of VR treatment will be assessed by qualitative report, an open-ended question where the participant is allowed to describe any concerns not covered by SAFTEE assessment. Data presented here is the number of participants that stated the treatment was Tolerated.
Measured: Immediately post-VR treatment
Safety of VR Treatment Assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) Assessment
The SAFTEE assessment will be used to assess adverse events during the trial by the number of participants that had any adverse events while on study.
Measured: baseline up to Immediately post-VR treatment
Change in Overall Treatment Experience Satisfaction
Efficacy will be assessed by the difference in overall treatment experience satisfaction (via Likert scale) between the pre-VR and VR treatment sessions. Total scores range from 0 to 10 with higher scores indicating higher satisfaction with the treatment experience.
Measured: Baseline, during and immediately post VR treatment session
Secondary outcomes (5)
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
The 5D-ASC measures altered states of consciousness and contains 94 items using visual analogue scales. Score for each will be calculated from 0 to 100 based on measurement of where the participant has drawn the line. Then each subscale is the median score from a pre-defined list of items (eg subscale 2 is median of items 9,81,94). Higher scores means more altered state of consciousness.
Measured: baseline, during VR treatment and Immediately post-VR treatment
Change in 5D-ASC Total Score
The 5D-ASC measures altered states of consciousness and contains 94 items (visual analogue scales. Score for each will be calculated from 0 to 100 based on measurement of where the participant has drawn the line. Total score is the median of all items. Higher scores means more altered state of consciousness.
Measured: baseline, during VR treatment and Immediately post-VR treatment
Change in The Clinician-Administered Dissociative States Scale (CADSS)
The CADSS is a 23 item structured clinical interview to assess state dissociation rated by clinicians. Each item is scored from 0 (not at all) to 4 (extreme). Total score range from 0-92 with higher scores indicating greater severity of dissociative experiences.
Measured: baseline, during VR and immediately post VR treatment
Change in Participant Experience
Participant experience will be assessed by self report on whether it was a "pleasant vs unpleasant experience"using a Likert scale. Scores from 0-10 with higher scores indicating a more pleasant experience.
Measured: baseline, during VR treatment and Immediately post-VR treatment
Change in Level of Relaxation
The "level of relaxation" will be scored using a Likert scale with total score range from 0 to 11. Higher scores indicate a higher level of relaxation.
Measured: baseline, during VR treatment and Immediately post-VR treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start11 Jul 2024
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sina Nikayin, MD, Principal investigator, Assistant Professor, Departement of Psychiatry, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139016
- Sponsor's protocol ID
- 2000036184
- Other IDs
- 000
- Acronym
- VR-KET
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2023
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment
- ClinicalTrials.gov ID
- NCT06139016
- Acronym / sponsor ID
- VR-KET / 2000036184
- Conditions
- Depression
- Keywords
- ketamine, esketamine, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Posted 29 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether these tools can improve the tolerability and effectiveness of treatment with ketamine/esketamine
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Virtual realityThis single arm will include all participants of the study, who will all receive the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be at least 18 years old
- Patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment Written consent for the study procedures
- Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.
Key exclusion criteria (6 listed)
- Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content.
- Difficulty in understanding spoken or written English
- Unable to provide informed consent
- Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment)
- Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityVirtual reality gear and content will be used to affect and control the audiovisual perception of patients during a single treatment with ketamine/esketamine | Device | Treatment group |
Primary outcome
Tolerability of VR Treatment Assessed by Qualitative Report
Time frame: Immediately post-VR treatment
Tolerability of VR treatment will be assessed by qualitative report, an open-ended question where the participant is allowed to describe any concerns not covered by SAFTEE assessment. Data presented here is the number of participants that stated the treatment was Tolerated.
Safety of VR Treatment Assessed by Systematic Assessment of Treatment Emergent Events (SAFTEE) Assessment
Time frame: baseline up to Immediately post-VR treatment
The SAFTEE assessment will be used to assess adverse events during the trial by the number of participants that had any adverse events while on study.
Change in Overall Treatment Experience Satisfaction
Time frame: Baseline, during and immediately post VR treatment session
Efficacy will be assessed by the difference in overall treatment experience satisfaction (via Likert scale) between the pre-VR and VR treatment sessions. Total scores range from 0 to 10 with higher scores indicating higher satisfaction with the treatment experience.
5 secondary outcomes
Change in 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC) Subscale Scores
Time frame: baseline, during VR treatment and Immediately post-VR treatment
Change in 5D-ASC Total Score
Time frame: baseline, during VR treatment and Immediately post-VR treatment
Change in The Clinician-Administered Dissociative States Scale (CADSS)
Time frame: baseline, during VR and immediately post VR treatment
Change in Participant Experience
Time frame: baseline, during VR treatment and Immediately post-VR treatment
Change in Level of Relaxation
Time frame: baseline, during VR treatment and Immediately post-VR treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sina Nikayin, MD principal investigator
Assistant Professor, Departement of Psychiatry, Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Depression, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of VR Treatment Assessed by Qualitative Report (time frame: Immediately post-VR treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.